Korea MFDS Defines Evidence for Post-Market Study Exemptions

South Korea's Ministry of Food and Drug Safety (MFDS) has specified the overseas-use evidence required when seeking a medical device post-market study exemption. Notice No. 2026-63, published on 31 August 2026, adds Article 9 to the regulation on medical device post-market studies (의료기기 시판 후 조사에 관한 규정).

This is a final MFDS notice, effective from the day it was issued, 31 August 2026. It supplies detailed criteria under the exemption framework in the Medical Devices Act Enforcement Rules. It is separate from the Enforcement Rules amendment proposed on 14 September, which remains a consultation.

Eligibility comes before the evidence package

Article 18(2) of the Enforcement Rules provides that MFDS may exempt an eligible device from the post-market study after deliberation by the Medical Device Committee. The overseas-experience route in Article 18(2)(2) concerns specified newly developed devices and orphan medical devices that have been authorized in a foreign country whose device safety management MFDS recognizes as equivalent to or higher than Korea's, and that have qualifying overseas-use experience.

The 1 July 2026 Enforcement Rules amendment added orphan devices to that route. The August notice provides the delegated evidence criteria; it should not be described as the first creation of an exemption power or as an exemption for every foreign-authorized device.

What the new Article 9 requires

The final amendment text defines qualifying overseas-use experience through an overall assessment of post-market clinical experience, safety information, and authorization and sales history. Together, that evidence must sufficiently establish safety and effectiveness.

Article 9(2) requires applicants to submit both evidence categories below to MFDS. The alternative in the first row is within that category; it does not make the second category optional.

The consolidated regulation shows what the Article 6 references encompass. They include evaluation of adverse-event information by characteristics of the treated population and by intended purpose, duration, method and outcome of use, as well as authorization and sales history and foreign regulatory actions concerning safety and effectiveness.

A foreign authorization certificate alone does not address those categories. Nor does Article 9 specify a universal minimum number of overseas years, patients or sales units, or promise approval within a fixed processing time.

What this change does not waive

The amendment adds the exemption criteria and renumbers the previous Articles 9–11 as Articles 10–12. It does not replace all post-market safety duties with an overseas-data submission. Article 8 continues to refer safety-information collection and reporting matters not covered by this regulation to the separate MFDS safety-information regulation.

There is no new application deadline or separate transition period in Notice No. 2026-63. The relevant decision is whether an eligible applicant can support an exemption request, not whether every device company must submit a new dossier.

Build the request around the two evidence categories

Pure Global analysis: first record the basis for eligibility under Article 18(2)(2), including the device category and relevant foreign authorization. Then organize the evidence into the two Article 9 categories and cross-reference the overseas safety analyses to the product's actual intended use and population. Identify gaps before asking MFDS to assess the request, particularly where an authorization certificate is available but post-market clinical or adverse-event analysis is incomplete.

Keep the exemption decision separate from the evidence-collection exercise: assembling a package does not itself grant an exemption. Maintain the applicable study and safety-reporting arrangements until the regulatory position for the device is established.

For the broader pathway, see South Korea medical device registration.